The SCARLET SRF includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the handpiece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SCARLET SRF creates heat within the target skin tissue via needle electrodes from the consumable tip.

AI/ML Overview

The provided document is a 510(k) summary for the SCARLET SRF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria as you might see for novel devices.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria, particularly in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score), MRMC studies, or multi-reader ground truth establishment, is not present in this document. The document describes pre-clinical performance testing related to safety and foundational operational aspects.

However, I can extract the information that is available about the performance data.

Here's the breakdown of the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of diagnostic or clinical outcome metrics. Instead, it lists various performance tests and states that the device "met the pre-set criteria" or that "all results were passing."

Test Category	Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Sterilization Validation	Sterility assurance level of 10-6 (EtO sterilization)	Verified sterility assurance level (10-6) using BI overkill method.
Shelf-life Validation	Maintain device integrity and functionality over proposed shelf life	Tests conducted using accelerated aging method.
Biocompatibility	Compliance with ISO 10993 standards for patient-contacting components	Tests conducted in accordance with ISO 10993 series and USP 39 <151>.
Software Validation	Software (firmware) performance for moderate level of concern	Validation tests performed.
EMC & Electrical Safety	Compliance with applicable IEC and EN standards	All results were passing.
Max Output Energy	Meet pre-set criteria for maximum output energy per electrode	Test results met pre-set criteria and validated specifications.
Preclinical (Animal) Study	Safety and effectiveness as an RF heating device; substantial equivalence to predicates	Demonstrated transient erythema, minimal to mild necrosis, dermal fibrosis, and no other application-related findings. Histology data supported substantial equivalence.

Important Note: The "acceptance criteria" here are largely inferred from the testing standards and the statement that the tests were successful. They are not quantifiable performance metrics like accuracy, sensitivity, or specificity.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Preclinical Animal Study: Three (3) Yucatan Mini-pigs.
- For other tests (Sterilization, Shelf-life, Biocompatibility, EMC, Electrical Safety, Max Output Energy, Software), the specific sample sizes are not explicitly stated for each test, but standard procedures for these tests would involve appropriate sample sizes of the device/components.
Data Provenance: The document does not specify the country of origin for the data (e.g., where the animal study was conducted, or where the other tests were performed). It is presumed to be conducted by or for VIOL Co., Ltd., based in South Korea, or their designated testing facilities.
Retrospective/Prospective: The preclinical animal study was prospective in design (monitoring animals over time after treatment). Other tests are typically prospective (i.e., conducted anew for this device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The preclinical animal study involved histopathology evaluation, which would typically be performed by veterinary pathologists, but the number or qualifications of these experts are not mentioned. For the other technical tests, "ground truth" as you might define it for AI or diagnostic devices does not directly apply; rather, it's about adherence to engineering standards and objective measurements.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of technical and preclinical (animal) tests described in this 510(k) summary. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessment where discrepancies between readers need to be resolved for ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described. This type of study is relevant for AI-powered diagnostic devices comparing human performance with and without AI assistance, which is not the nature of the SCARLET SRF device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm-only performance study was not done and is not described. The SCARLET SRF is an electrosurgical device, not an AI or diagnostic algorithm, so this type of study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the Preclinical Animal Study: Histopathology evaluation was used to assess the tissue changes.
For other engineering and safety tests: The "ground truth" is adherence to established international and national standards (e.g., ISO, ASTM, IEC, EN, USP) and the device's own pre-set design specifications. This is based on objective measurements and standard compliance.

8. The sample size for the training set

This information is not applicable and not provided. The SCARLET SRF is an electrosurgical device; it does not involve machine learning algorithms that require a "training set" in the context of AI development.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this device in the context of AI.

Summary

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October 11, 2018

VIOl Co., Ltd. % Mina Joo Assistant Manager BT Solutions, Inc. 91-14 Seolleung-ro #402 Gangnam-gu Seoul, Korea 06150

Re: K180872

Trade/Device Name: SCARLET SRF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 11, 2018 Received: September 13, 2018

Dear Mina Joo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lo
20
-C

Long H. Chen -S 2018.10.11 07:58:57 -04'00'

for

Binita S. Ashar. M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180872

Device Name SCARLET SRF

Indications for Use (Describe)

The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

1. General Information

Applicant/Submitter:	VIOL Co., Ltd.
Address:	C-808, 809, Bundang Technopark C,744, Pangyo-ro, Bundang-gu, Seongnam-si,Gyeonggi-do (13510), South Korea
	Tel) +82-31-8017-7893Fax) +82-31-8016-7894
Contact Person:	Mina Joo, BT Solutions, Inc.
Address:	91-14 Seolleung-ro, #402Gangnam-gu Seoul, 06150Republic of KoreaTel) +82.2.538.9140Email) smanager@btsolutions.co.kr
Preparation Date:	September-5-2018

2. Device Name and Code

Device Trade Name:	SCARLET SRF
Common Name:	Radiofrequency System
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Product Code:	GEI
Regulation Number:	878.4400
Classification:	Class II
Review Panel:	General & Plastic Surgery

3. Predicate Devices

Scarlet SRF is substantially equivalent to the following devices

	Table 5.1 Predicate devices
--	-----------------------------	--

Applicant	Device Name	510(k) Number
Lutronic Corporation	INFINI Radiofrequency System	K121481

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Scarlet SRF 510(k) Summary

Table 5.2 Reference devices *

Applicant	Device Name	510(k) Number
Sung Hwan E&B Co., Ltd.	VIVACE Electrosurgical	K150409

*This reference device is referred, of which similarity of having smaller number of non-insulated needles when compare to the same predicate device.

4. Device Description

SCARLET SRF is basically an identical device with the 510(k)-cleared device CELFIRM™ (K172023).

5. Indications / Intended Use

The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

6. Technical Characteristics in Comparison to Predicate Devices

	Predicate Device	Proposed Device
510(K) Number	K121481	N/A
Manufacturer	Lutronic Corporation	VIOL Co., Ltd.
Device Name	INFINI Radiofrequency System	SCARLET SRF
Clearance Date:	Jun 25,2013	N/A
Classification /Regulation	Class II/21 CFR 878.4400Electrosurgical, Cutting & Coagulation& Accessories	Class II/21 CFR 878.4400Electrosurgical, Cutting & Coagulation& Accessories
Product Code	GEI	GEI
Intended Use/Indications forUse	The INFINI Radiofrequency System isintended for use in dermatologic andgeneral surgical procedures forelectrocoagulation and hemostasis, andthe percutaneous treatment of facialwrinkles.	The SCARLET SRF is intended for usein dermatologic and general surgicalprocedures for electrocoagulation andhemostasis.
Intended for	Prescription Use	Prescription Use
RF Output Type	BiPolar	BiPolar

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Scarlet SRF 510(k) Summary

Electrodeexposure(Depth)
Output Control	Foot switch	Foot / Finger switch
ElectrodeMaterial	Gold plated (Surgical stainless steel)	Gold plated (Surgical stainless steel)
No. of usage	Single use	Single use
Sterilization	EO gas sterilization	EO gas sterilization
Spot size	$10 \times 10$ (mm)	$10 \times 10$ (mm)
	0.5-3.5 mm (Unit: 0.1)	0.5-3.5 mm (Unit: 0.25)

7. Performance Data

SCALRET SRF is basically an identical device with the 510(k)-cleared device CELFIRM™.

Sterilization Validation, Shelf life Validation, Biocompatibility, Software Validation, EMC & Electrical Safety Test, Max Output Energy, and Animal Test were conducted on the subject device.

Sterilization Validation Test

To verify the sterility assurance level (10-6) for EtO sterilization and biological indicator (BI) overkill method was used in accordance to ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2012.

Shelf life Validation Test

The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 (2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The referenced standards for the testing are ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USPNF.

Biocompatibility Test

The patient contacting component of the subject device is the Consumable Tip and the biocompatibility tests were in accordance with ISO 10993-5. ISO 10993-7. ISO 10993-10, ISO 10993-11, and USP 39 <151>.

Software Validation Test

The level of concern of the software (firmware) of the SCARLET SRF is moderate and the software validation tests were performed.

EMC & Electrical Safety Test

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Scarlet SRF

510(k) Summary

The subject device has been evaluated for electromagnetic compatibility and electrical safety testing per applicable standards of IEC 60601-1:2005, IEC 6061-1-6:2010, IEC 60601-2-2:2009, EN 60601-1-2:2007, EN 6100-3-2:2006, and EN 6100-3-3:2008, and all results were passing.

Max Output Energy

The test on Max Output Energy per Electrode was performed on the subject device to evaluate the max energy per electrode. The test results were compared and evaluated with the standard values of maximum output energy per Electrode of the device. The test results met the pre-set criteria and validated the device performance specifications for max energy.

Preclinical Test

The study was designed to evaluate the safety and effectiveness of the subject device as a radiofrequency(RF) heating device to treat dermal conditions and hemostasis. Three (3) Yucatan Mini-pigs were used in this study. Animal 2162 was euthanized 3 h after treatment on Day 1;

Animal 2163 was euthanized on Day 4; and Animals 2164 was euthanized on Day 22. The various treatment sites were then harvested and stored in a 10% NBF prior to histopathology evaluation. During the in-life stage, mortality, clinical observations and body weights were monitored and recorded. In addition, dermal Draize scores were recorded within 3-4 h of treatment, and on Days 3, 5, 13, and 22 in surviving animals.

Treatment with the subject device resulted in transient very slight to well-defined erythema noted within 3-4 h of treatment but fully resolved by the next Draize evaluation on Day 3. In addition, minimal to mild necrosis was noted in animals euthanized on Days 1 and 5 with the animal euthanized on Day 22 showing dermal fibrosis at the treatment sites. There were no other application-related findings.

Test results including histology data demonstrated that the subject device is substantially equivalent to the predicate devices in the market for its intended use.

8. Substantial Equivalence

The intended use of the SCARLET SRF is within the scope of the predicate device. SCARLET SRF, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses. Based upon the predicted overall performance characteristics for the SCARLET SRF, VIOL Co., Ltd., believes that no significant differences exist in usage of its underlying technological principles between SCARLET SRF and the cited predicate device.

9. Conclusions

Based on the information provided in this premarket notification. VIOL Co., Ltd. concludes that the SCARLET SRF is substantially equivalent to the predicate device as described herein.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.